BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 19242502 · Received May 3, 2024

    Report

    Report Number
    3011270181-2024-00046
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 4, 2024
    Report Date
    October 14, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K220588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-MAY-2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVIE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CLINICIAN "ATTEMPTED DOBB-HOFF PLACEMENT. THE CORTRAK-2 APPEARED TO BE WORKING CORRECTLY AT [FIRST] ATTEMPT. PATIENT WAS AGITATED SO ATTEMPT ABORTED. WHEN ATTEMPTING TO PLACE AN HOUR LATER. THE TRANSMITTER DID NOT PICK UP THE SENSOR AND WAS CUTTING IN AND OUT. ALSO, THE POINT FUNCTION [WAS] GRAYED OUT DESPITE POINTER BEING ON. THE TRACING [WAS] AVAILABLE FOR THE FIRST ATTEMPT. AN X-RAY WAS DONE ONCE THE PATIENT DEMONSTRATED RESPIRATORY DISTRESS AND IT WAS CONFIRMED THAT PATIENT LEFT LUNG PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND PATIENT IS CURRENTLY INTUBATED... THE CORTRAK UNIT WAS PLACED ACROSS THE BED AND THE RECEIVER WAS FRONT FOOT AT XIPHOID PROCESS. PATIENT HAS ATYPICAL ANATOMY. NO IMPLANTED MEDICAL DEVICES TO AFFECT THE ELECTROMAGNETIC FIELDS. MULTIPLE ATTEMPTS TO RESOLVE OUT OF RANGE BY RESTARTING THE TRACING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101419 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other RECEIVER UNIT #20120862| UNKNOWN NGT